MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) powering off during patient use occurring on (b)(6) 2018 was not reproduced during functional testing of platform.There was no device deficiency found during evaluation of the platform to indicate a functional issue.The device was functionally tested using a good known autopulse li-ion battery first with a test mannequin operating for 15 minutes and a large resuscitation test fixture for 34 minutes and operated with compression without error.A lifeband clip detect switch inspection was performed and verified that the switch is within specification.The investigation performed a load characterization check and verified that the load cells are within specification.Review of the archive data confirmed the occurrence of multiple user advisory (ua) error messages on (b)(6) 2018.The events recorded on (b)(6) 2018 indicated that the platform was used and displayed ua 2 (compression tracking error), ua 45 (not at "home" position after power-on/restart), ua 18 (max take-up revolution exceeded), ua 42 (force overload tripped), and ua 19 (max applied load exceeded) error messages.On (b)(6) 2018, the platform displayed ua 45 and ua 18 error messages.On both of these events, the user was unable to clear the error messages.These events are what the user likely experienced on the reported event date, the issue is attributed to user error.This confirms the reported complaint.Note that user advisory error messages are designed into the platform when one of several conditions is detected.The ua 2 alerts the operator that as the drive shaft rotates and shortens/tightens the lifeband (compresses the chest), the load sensors do not see the expected increase in load.The ua 45 indicates that the drive shaft is not at the home position when the autopulse is powered on.The ua 18 indicates that during takeup, the driveshaft has moved the lifeband past the maximum allowable takeup depth without detecting a patient.The ua 42 indicates a fan malfunction.The ua 19 alerts that the load plate has detected too much weight being applied these user advisories will persist until the lifeband is properly installed and the driveshaft is returned to its home position.Per the autopulse user guide instructions, to clear the ua error messages, the operator needs to pull up the lifeband until the chest bands are full extended.This action will move the driveshaft to its home position.The patient should be properly positioned ontop of the platform.Restarting the platform will clear the ua error messages.As part of routine service during testing, the device was examined and found physical damage.This observation is unrelated to the reported event and is attributed to mishandling.After replacement of the damaged part, the platform was further functionally tested and passed full specification.Historical complaints were reviewed for service information related to the reported complaint and no similar complaint was reported for the autopulse platform with serial number (b)(4).

Event Description

At an unspecified date around (b)(6) 2018, the autopulse platform did not function as intended during trial.The platform powered off during use on a patient.The reporter was unable to specify if the platform performed compression.Following this, manual cpr was immediately administered.The length of delay was not specified.No further information was provided at this time.No known impact or consequence to patient.This represents the second customer reported issue on the platform.Reference mfr 3010617000-2018-00491 for the first reported issue involving the returned autopulse platform.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7497242
• MDR Text Key: 107694540
• Report Number: 3010617000-2018-00443
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1